UNISTAT BILIRUBINOMETER— 510(k) K781241

Substantially Equivalent

American Optical Corp.

FDA 510(k) clearance K781241 for UNISTAT BILIRUBINOMETER, Substantially Equivalent on 1978-08-14. Applicant: American Optical Corp.. Device class: 1.

Clearance details

Applicant: American Optical Corp.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1978-07-19
Decision date: 1978-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.